News
FDA Oncologic Drugs Advisory Committee voted in favor of maintaining accelerated approval of Tecentriq + Abraxane, for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer. Genentech/Roche
-Genentech/Roche announced the FDA Oncologic Drugs Advisory Committee (ODAC) voted 7 to 2 in favor of maintaining accelerated approval of Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane, albumin-bound paclitaxel; nab -paclitaxel) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1, as determined by an FDA-approved test.
The ODAC meeting is part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. The advisory committee provides the FDA with independent opinions and recommendations from outside medical experts, though the recommendations are not binding. The FDA has not announced when it will make its final decision for Tecentriq in this indication.
Condition: Breast Cancer Triple Neg
Type: drug
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